1. James Hermiller, MD, FACC, FSCAI St Vincent Hospital, Indianapolis, IN
Structural Heart & Valve FDA Workshop - February 22, Debate #5 The Enemy of Good is Better?: Percutaneous Mitral Valve Procedures Don’t Have to Match Open Surgical Results
James Hermiller, MD, FACC, FSCAI St Vincent Hospital, Indianapolis, IN

2. Disclosure Information The following relationship exists: Grant support: Evalve EVEREST Studies Consultant for Abbott

3. Euro Heart Survey: Surgery is often denied in the older patients
Isolated MR
(n=877)
Severe MR
(n=546)
No Severe MR
(n=331)
2/3 of symptomatic MR patients >70 are denied surgery
Symptoms
(n=396)
No Symptoms
(n=144)
No Intervention
(n=193) 49%
Intervention
(n=203) 51%
Mirabel et al, European Heart J 2007;28: 3

4. Surgery vs Percutaneous Repair
Large group of patients who have severe mitral regurgitation who surgical correction is not an option (or not offered)
In these non-surgical patients clearly percutaneous mitral valve procedures don’t have to match open surgical results; compare to medical therapy/CRT alone

5. Euro Heart Survey: Isolated MR (n=877) Severe MR No Severe MR (n=546)
Symptoms
(n=396)
No Symptoms
(n=144)
No Intervention
(n=193) 49%
Intervention
(n=203) 51%
Mirabel et al, European Heart J 2007;28: 8

6. EFFICACY INVASIVENESS Goal Traditional Less invasive surgery
BAD
Traditional
surgery
Less invasive
Goal
Percutaneous
techniques
EFFICACY
INVASIVENESS 9

7. The Balance Percutaneous Repair Surgical Repair Less Invasive
Lower Morbidity
More Rapid Return to Function
Surgical Repair
Long Term Outcome Known
Better Efficacy – Less MR and
Durable

8. Surgery vs Percutaneous Repair
The Efficacy Metric
MR reduction by echocardiography
Is zero/trivial MR better than 2+???
Symptom relief
Mortality

9. MR Reduction and Remodeling
LVEDVI and LVESVI
(Indexed Volumes)
MitraClip Therapy:
Significant Reverse LV Remodeling
P<.0001
P=.0007 89 74 36 31
Diastolic
Systolic
Baseline
12 Months
12 month matched data, n=47, MR≤2 at 12 months

10. EVEREST Preliminary FMR Cohort: NYHA Class
75% (9/12) Improved
17% (2/12) No Change
8% (1/12) Worsened w/o MR > 1+
Freedom from NYHA Class III or IV from 25% to 75%”
Patients included in the Matched Pair Analysis at 12-m:
, , , , , , , , , , ,

11. Is a Ticket Burned?
Are Surgical Options Preserved?

12. Flow chart :Outcomes of patients who had surgery after a clip attempt.
Mitral valve (MV) repair with the use of a surgical approach
to create a double-orifice valve was first performed by Alfieri
in 1991 (Fig. 1) (1–3). Durable results in surgically-treated
patients without annuloplasty have been described in selected
patients for as long as 12 years after surgical repair
(4,5). Percutaneous mitral repair based on this surgical
technique has been developed by the use of a clip rather than
suture to secure the mitral leaflets (6,7). The
Feldman et al. JACC, 2009:686–94

13. If a Bridge Isn’t Burned – Any Harm in Delaying/Avoiding Surgical Intervention?

14. Recurrence of Mitral Valve Regurgitation After Mitral Valve Repair in Degenerative Valve Disease Willem Flameng, MD, PhD; Paul Herijgers, MD, PhD; Kris Bogaerts, MSc
Freedom from severe MR (>2/4) was 18% at 5 yrs and 29% at 7 yrs
Circulation. 2003;107:

15. Conclusions
Large group of patients not offered surgical option – in these (at least half) percutaneous repair clearly does not have to match surgical results
In those with a surgical option, less procedural morbidity/mortality, more rapid return to function, preservation of surgical options, and limitations of surgical repair, suggests that percutaneous mitral valve procedures don’t have to match open surgical results